Functional Brain Imaging of Medication Treatment Response in Mild Alzheimer's Disease Patients
Information source: Duke University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: Razadyne ER (Drug); Aricept (Drug)
Phase: Phase 4
Sponsored by: Duke University
Official(s) and/or principal investigator(s):
Jeffrey N Browndyke, PhD, Principal Investigator, Affiliation: Duke University
Roberto Cabeza, PhD, Principal Investigator, Affiliation: Duke University
James R Burke, PhD, Principal Investigator, Affiliation: Duke University
Kathleen Welsh-Bohmer, PhD, Principal Investigator, Affiliation: Duke University
The purpose of this study is to determine whether standard medications approved for
Alzheimer's disease treatment differ in their action on brain functioning and whether any
observed brain activity differences as result of treatment are associated with particular
patterns of dementia improvement or reduced decline.
Official title: Functional Neuroimaging (fMRI) Biomarker of Allosteric Nicotinic Receptor Modulation in Mild Alzheimer's Disease Patients: A Razadyne vs. Aricept Dose Escalation Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Brain activity patterns, as collected via functional magnetic resonance imaging (fMRI), at rest and associated with task performance after 4 weeks of low-dose treatment and after 8-weeks of higher-dose treatment.
Secondary outcome: Differences in cognitive testing and functional status at pre-treatment baseline and after completion of the 12-week treatment trial.
This study seeks to differentiate task-related and resting brain activity patterns captured
via functional magnetic resonance imaging (fMRI) and associated with two common Alzheimer's
disease (AD) medications, equivalent in acetylcholinesterase inhibition effect (AChEI) but
differing with respect to allosteric nicotinic receptor modulation effect. It is the primary
aim of this project to gain a better understanding of the brain mechanisms involved in the
attentional and executive skills improvements associated with nicotinic receptor modulation
in mild AD patients.
To address this question, this 12-week continuous treatment, double-blind, head-to-head
dose-escalation treatment trial seeks to visualize any treatment response unique to
allosteric nicotinic receptor modulation and to associate these fMRI data with standard
cognitive assessment outcomes. Using in-scanner tasks shown to reliably elicit brain
activity in cortical regions important to memory and attention, this treatment trial will
examine both resting and task-related BOLD signal characteristics in a well-characterized
sample of 36 mild AD patients after periods of low dose and high dose AD dementia treatment
with either galantamine hydrobromide (AChEI + nicotinic receptor modulation) or donepezil
hydrochloride (AChEI only). Both the low and high dose imaging comparisons between treatment
groups will be equivalent for 35% AChEI-effect, which may allow for the isolation of BOLD
signal unique to allosteric nicotinic receptor modulation in both brain at rest and
task-related brain states.
Minimum age: 40 Years.
Maximum age: 90 Years.
- Must meet diagnosis of mild Alzheimer's disease
- Must have a family member or caregiver who is willing to attend all study visits and
provide information on your participation in the study
- If female, must be post-menopausal
- Must be able to swallow tablets
- Metal implants or medical devises unsafe for MRI use
- Pre-menopausal female
- HIstory of recent head injury
- Significant major, life-threatening illness or injury (e. g., stroke, AIDS, etc.)
- Vascular dementia or any dementia other than Alzheimer's Disease
- History of significant alcoholism or drug abuse
- History of seizure disorder, developmental delay or major psychiatric illness
Locations and Contacts
Joseph & Kathleen Bryan Alzheimer's Disease Research Unit, Durham, North Carolina 27705, United States
Starting date: October 2006
Ending date: November 2007
Last updated: June 3, 2008